Hydraulic urinary incontinence treatment apparatus

ABSTRACT

A urinary incontinence treatment apparatus comprises an adjustable restriction device ( 234 ) implanted in a patient, who suffers from urinary incontinence. The restriction device engages the urethra ( 244 ) of the patient to restrict, i.e. to close the urine passageway. An implanted adjustment device is adapted to adjust the restriction device such that the urethra is temporarily released, in order to open the urine passageway when the patient wants to urinate. An implanted powered hydraulic operation device ( 246 ) operates the adjustment device.

[0001] The present invention relates to a urinary incontinence treatmentapparatus, comprising an adjustable restriction device adapted to engagethe urethra or urine bladder of a patient, who suffers from urinaryincontinence, to form a restricted urine passageway in the urethra orurine bladder. An implantable adjustment device is provided foradjusting the restriction device to restrict the urethra or urinebladder to close the urine passageway, or release the urethra or urinebladder to open the urine passageway, when the restriction device isimplanted in the patient. An implantable operation device is providedfor operating the adjustment device.

[0002] Urine incontinence is a widespread problem. Many people arehelped through training of the muscles in the pelvic floor but too manyhave severe problems with urine leakage. Many different solutions tothis problem have been tried. There is a prior manually operatedsphincter system connected to an elastic reservoir/pump placed in thescrotum or in the region of the labia majora. A disadvantage of thissystem is that over time hard fibrosis is developed around the reservoirwhich may cause malfunction of pumping components and it is rathercomplicated to manually squeeze the elastic reservoir when urinating,especially woman can get their fingers wet. Thus, the created fibrosiswill sooner or later become a hard fibrotic layer which may make itdifficult to pump the reservoir. Yet a further disadvantage is that theuse of hydraulic fluid always entails a risk of fluid leaking from theprosthetis. Furthermore, it is a rather complicated task to manuallypump the reservoir when needing to urinate.

[0003] A prior hydraulic device which is made for compressing theurethra is disclosed in U.S. Pat. No. 5,520,606. Prosthetic sphincterswith an inflateable cuff which surrounds the urethra or encloses it ontwo sides are disclosed in for example U.S. Pat. Nos. 4,571,749 and4,222,377. U.S. Pat. No. 4,969,474 discloses a hydraulic method fortreating both men and women with urinary incontinence problem in thesame way. The apparatus of the U.S. Pat. No. 4,969,474 includes areservoir containing fluid and an inflatable compression device thatwill compress urethra without risking tissue loss or necrosis to occur.An artificial hydraulically operated urethral sphincter employing anexternal magnet to achieve closure of the urethral cuff is disclosed inU.S. Pat. Nos. 5,562,598. A prior mechanical prosthetic sphincter,disclosed in. U.S. Pat. No. 4,619,245 comprises a manually controllableactuating component for implanting at a convenient location in thepatients body.

[0004] A prime object of the present invention is to provide a urinaryincontinence treatment apparatus, which does not require manualmanipulation of a combined reservoir and pump mechanism placed in thescrotum or in the region of the labia majora of the patient.

[0005] Another object of the invention is to provide an urinaryincontinence treatment apparatus, which does not require complicatedsurgery.

[0006] Yet another object of the invention is to provide an urinaryincontinence treatment apparatus, which may be conveniently controlledby the patient with a remote control.

[0007] These objects are obtained by an apparatus of the kind describedinitially characterised in that the operation device comprises a poweredoperation device and/or a servo means.

[0008] The expression “powered” should be understood as energised witheverything without manual force, preferably electric energy. In otherwords, the adjustment device is operated in a non-manual manner. Theexpression “non-manual manner” should be understood to mean that theadjustment device is not operated by manually touching subcutaneouslyimplanted components of the apparatus or not manipulated by touching theskin of the patient. Thus, as opposed to prior practice when treatingurine incontinence, the adjustment device of the invention is notoperated by manual forces, such as by manually compressing a fluidcontaining balloon implanted in the scrotum or in the region of labiamajora. Of course, manual manipulation of a subcutaneous start button orthe like for activating the powered operation device is permitted withinthe scope of the present invention.

[0009] Alternatively, or in combination with a powered operation device,the servo means may be used, which enables manual manipulation withoutneed for strong manipulation forces. The servo means may comprisehydraulic means, electric control means, magnetic means, or mechanicalmeans, which may be activated by manual manipulating means. Using aservo system will save the use of force when adjusting the adjustmentdevice, which may be of importance in many applications.

[0010] The term “servo means” encompasses the normal definition of aservo mechanism, i.e. an automatic device that controls large amounts ofpower by means of very small amounts of power, but may alternatively oradditionally encompass the definition of a mechanism that transfers aweak force acting on a moving element having a long stroke into a strongforce acting on another moving element having a short stroke. The servomeans may comprise a motor, preferably an electric motor, which may bereversible.

[0011] In accordance with a main embodiment of the invention, theapparatus comprises a reservoir, preferably containing a predeterminedamount of hydraulic fluid, also implantable in the patient, wherein theoperation device, suitably electrically powered, operates the adjustmentdevice by using the hydraulic fluid of the reservoir.

[0012] The adjustment device may comprise an expandable cavity in therestriction device, wherein the urethra or urine bladder is squeezedupon expansion of the cavity and released upon contraction of thecavity. In this embodiment the operation device is adapted to distributehydraulic fluid from the reservoir to expand the cavity, and from thecavity to the reservoir to contract the cavity.

[0013] A fluid distribution tube may readily be connected between thereservoir and the cavity in a manner so that the tube does not interferewith other implanted components of the apparatus.

[0014] Preferably, the reservoir defines a chamber for the predeterminedamount of fluid and the operation device changes the volume of thechamber. The operation device suitably comprises first and second wallportions of the reservoir and is adapted to provide relativedisplacement between the first and second wall portions of thereservoir, in order to change the volume of the chamber.

[0015] The operation device may be adapted to provide said relativedisplacement in response to the pressure in the reservoir. Suitably, theoperation device comprises a pressure controlled hydraulic operationdevice. For safety, an alarm may be provided for generating an alarmsignal in response to the lapse of a predetermined time period duringwhich the pressure-controlling the hydraulic operation device exceeds apredetermined high value.

[0016] Suitably, the operation device is adapted to distribute fluidfrom the reservoir to the cavity of the restriction member in responseto a predetermined first displacement of the first wall portion of thereservoir relative to the second wall portion of the reservoir and maydistribute fluid from the cavity to the reservoir in response to apredetermined second displacement of the first wall portion relative tothe second wall portion.

[0017] The first and second wall portions of the reservoir may bedisplaceable relative to each other by a magnetic, hydraulic, orelectric power means, such as an electric motor. In this embodiment nopump is used, only the volume of the reservoir is varied. This is ofgreat advantage compared to the solution described below when theoperation device comprises a pump used to pump fluid between thereservoir and the adjustment device because there is no need for anon-return valve and it is still possible to have fluid going both toand from the reservoir. Thus, the significant risk of malfunction whenusing such a non-return valve implanted in the patient is eliminated.

[0018] The operation device may comprise hydraulic means and a fluidconduit extending between the hydraulic means and the adjustment device.The hydraulic means and conduit are devoid of any non-return valve. Thereservoir may form part of the conduit and a fluid chamber with avariable volume. The operation device may distribute fluid from thefluid chamber to the adjustment device by reduction of the volume of thechamber and withdraw fluid from the adjustment device by expansion ofthe volume of the chamber. The operation device preferably comprises amotor for moving a movable wall of the reservoir for changing the volumeof the chamber. Any kind of motor could be used for the differentoperations as well as wireless remote solutions for controlling theoperations.

[0019] The restriction device preferably is operable to perform areversible function and accordingly there is a reversing deviceimplantable in the patient for reversing the function performed by therestriction device. Such a reversing function preferably involvesenlarging and restricting the urine passageway by the restrictiondevice, suitably in a stepless manner. In this connection, the controldevice suitably controls the reversing device, which may include aswitch, to reverse the function performed by the restriction device. Thereversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gearbox.

[0020] Where the reversing device comprises a switch the control devicesuitably controls the operation of the switch by shifting polarity ofreleased energy supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch. The switch mentioned above may comprise anelectronic switch or, where applicable, a mechanical switch.

[0021] Where the operation device comprises a motor, the reversingdevice is adapted to reverse the motor.

[0022] In accordance with another particular embodiment of theinvention, the operation device comprises a pump for pumping fluidbetween the reservoir and the adjustment device. A mechanical solutionis proposed in which it is possible to pump fluid from the reservoir tothe adjustment device and vice versa just by pushing an activationmember in one direction. The pump preferably comprises a firstactivation member for activating the pump to pump fluid from thereservoir to the adjustment device, and a second activation member foractivating the pump to pump fluid from the adjustment device to thereservoir. At least one of the first and second activation members maybe operable by manual manipulation, preferably to permit manual pushing,pulling or rotation thereof in one direction, or by a device poweredmagnetically, hydraulically, or electrically (e.g. by an electricmotor), or be operable by a combination of these methods. Suitably, atleast one of the activation members may be adapted to operate whensubjected to an external pressure exceeding a predtermined magnitude.

[0023] Another alternative is a pump pumping in only one direction andan adjustable valve to change the direction of fluid to either increaseor decrease the amount of fluid in the reservoir. This valve may bemanipulated either manually, mechanically, magnetically, orhydraulically.

[0024] The main embodiment of the invention described above includingthe reservoir may alternatively be equipped with a servo meanscomprising a reverse servo. The term “reverse servo” is to be understoodas a mechanism that transfers a strong force acting on a moving elementhaving a short stroke into a weak force acting on another moving elementhaving a long stroke; i.e. the reverse function of the above-definedalternative mechanism of a normal servo mechanism. A first closedhydraulic system that controls another closed hydraulic system in whichhydraulic means of the adjustment device is incorporated may be used.Minor changes in the amount of fluid in a smaller reservoir of the firstsystem could then be transferred by the reverse servo into major changesin the amount of fluid in a larger reservoir in the second system. Inconsequence, the change of volume in the larger reservoir of the secondsystem affects the hydraulic means of the adjustment device. Forexample, a short stroke that decreases the volume of the smallerreservoir will cause the larger reservoir to supply the adjustmentdevice with a large amount of hydraulic fluid, which in turn results ina long mechanical adjustment stroke on the restriction device.

[0025] The great advantage of using such a reverse servo is that thelarger volume system could be placed inside the abdomen orretroperitoneum where there is more space and still it would be possibleto use manual manipulation means of the smaller system subcutaneously.The smaller reservoir could be controlled directly or indirectly by afluid supply means. The fluid supply means may include another smallreservoir, which may be placed subcutaneously and may be activated bymanual manipulation means. Both the normal servo means and the specificreverse servo may be used in connection with all of the variouscomponents and solutions described in the present specification.

[0026] Thus, the reverse servo may be adapted to provide relativedisplacement between the first and second wall portions of thereservoir, suitably in response to the pressure in the reservoir, inorder to change the volume of the chamber of the reservoir.

[0027] Generally, the servo means, including the reverse servo,comprises a pressure controlled servo means. The alarm mentioned abovemay alternatively be adapted to generate an alarm signal in response tothe lapse of a predetermined time period during which the pressurecontrolling the servo means exceeds a predetermined high value.

[0028] The reverse servo may comprise magnetic means, electric means ormanual manipulation means or a combination thereof. Preferably, however,the reverse servo comprises hydraulic means.

[0029] In accordance with a particular embodiment of the invention, thereverse servo further comprises a servo reservoir defining a chambercontaining servo fluid, and the operation device comprise first andsecond wall portions of the servo reservoir, which are displaceablerelative to each other to change the volume of the chamber of the servoreservoir. The first and second wall portions of the servo reservoir maybe displaceable relative to each other by magnetic means, hydraulicmeans, or electric control means.

[0030] Where the reverse servo comprises hydraulic means it may furthercomprise a fluid supply reservoir connected to the servo reservoir in aclosed system and containing a further predetermined amount of fluid.The fluid supply reservoir defines a chamber for the furtherpredetermined amount of fluid and the operation device is adapted tochange the volume of the chamber and thereby control the amount of fluidin the servo reservoir. The fluid supply reservoir comprises first andsecond wall portions, which are displaceable relative to each other tochange the volume of the chamber of the fluid supply reservoir.Suitably, the fluid supply reservoir increases the amount of fluid inthe servo reservoir in response to a predetermined first displacement ofthe first wall portion of the fluid supply reservoir relative to thesecond wall portion of the fluid supply reservoir and decreases theamount of fluid in the servo reservoir in response to a predeterminedsecond displacement of the first wall portion of the fluid supplyreservoir relative to the second wall portion of the fluid supplyreservoir.

[0031] In accordance with an embodiment of the invention, the adjustmentdevice comprises a hydraulic adjustment device, and an implantablereservoir containing a predetermined amount of hydraulic fluid and aconduit providing fluid connection between the reservoir and thehydraulic adjustment device are provided. The operation device isadapted to operate the hydraulic adjustment device by distributinghydraulic fluid through the conduit between the reservoir and thehydraulic adjustment device, wherein the conduit and hydraulicadjustment device are devoid of any non-return valve to permit free flowof hydraulic fluid in both directions in the conduit. Preferably, thereservoir forms a fluid chamber with a variable volume, and theoperation device is adapted to distribute fluid from the chamber to theadjustment device by reduction of the volume of the chamber and towithdraw fluid from the adjustment device by expansion of the volume ofthe chamber. The operation device may comprise a motor or a pump.Alternatively, the operation device may comprise a movable wall of thereservoir for changing the volume of the chamber. For example, theoperation device may be adapted to change the volume of the chamber bymoving the movable wall in response to the pressure in the chamber.

[0032] In the above embodiments including a reservoir for hydraulicfluid an injection port may be provided for subcutaneous implantation inthe patient to be in fluid communication with the chamber of thereservoir. The injection port may be integrated in the reservoir. Suchan injection port may be provided for enabling, normally single,once-and-for-all, calibration of the amount of fluid in the hydraulicsystem used.

[0033] In the various embodiments hereinafter described the restrictiondevice generally forms an at least substantially closed loop. However,the restriction device may take a variety of different shapes, such asthe shape of a square, rectangle or ellipse. The substantially closedloop could for example be totally flat, i.e. thin as seen in the radialdirection. The shape of restriction device may also be changed duringuse, by rotation or movements of the restriction device in anydirection. A physical lumen, like the urethra or urine bladder, often iseasier to restrict by contracting two opposite sidewalls of the lumenagainst each other. Thus, the restriction device may be designed toperform such a contracting effect of the opposite walls of the urethraor urine bladder. Either mechanical or hydraulic solutions may beemployed to operate the restriction device. Alternatively, therestriction device may comprise an adjustable cuff, a clamp or a rollerfor bending or rotating the urethra or urine bladder to close itspassageway. Such a cuff, clamp or roller may also be utilized forsqueezing the urethra or urine bladder against human material inside thebody of the patient, for example the sacral bone of the patient, oragainst implanted structures of the apparatus. The bending or rotatingmembers may take any shape and be either hydraulic or non-inflatable.

[0034] Preferably the restriction device comprises an elongatedrestriction member and forming means for forming the restriction memberinto at least a substantially closed loop around the urethra or urinebladder, wherein the loop defines a restriction opening, whereby theadjustment device adjusts the restriction member in the loop to changethe size of the restriction opening.

[0035] Advantageously, the forming means may form the restriction memberinto a loop having a predetermined size. Alternatively, the formingmeans may form the restriction member into a loop having a size selectedfrom several predetermined sizes.

[0036] The adjustment device may change the size of the restrictionopening such that the outer circumferential confinement surface of therestriction member either is changed or is unchanged.

[0037] The elongated restriction member may be flexible, for exampletake the shape of a belt or cord, and the adjustment device may pull afirst portion of the flexible restriction member from a second portionof the flexible restriction member opposite the first portion in theloop to squeeze the urethra or urine bladder between the oppositelengths of the elongated flexible restriction member to restrict theurine passageway. The restriction member may be non-inflatable, and theadjustment device may mechanically adjust the restriction member in theloop.

[0038] The adjustment device may mechanically or hydraulically adjustthe restriction device. In the embodiments described the adjustmentdevice may either mechanically or hydraulically adjust the restrictiondevice, where applicable. It should be noted that the operation devicemight mechanically or hydraulically operate the adjustment deviceirrespectively of whether the adjustment device is adapted to adjust therestriction device mechanically or hydraulically.

[0039] In accordance with an embodiment of the invention, therestriction device comprises at least two elements on opposite ordifferent sides of the urethra or urine bladder, and the adjustmentdevice decreases the distance between the elements to squeeze theurethra or urine bladder between the elements, thereby restricting theurine passageway. It is also possible to use only one element andsqueeze the urethra or urine bladder against human bone or tissue. Theelements above may as well as all the restriction members mentioned inthis application be everything from rigid to soft.

[0040] In accordance with an alternative, the restriction device bendsor rotates a portion of the urethra or urine bladder to restrict theurine passageway in the same. For example, the restriction device maycomprise at least two bending members, such as cylindrical or hour-glassshaped rollers, positioned on opposite or different sides of the urethraor urine bladder and displaced relative to each other along the urethraor urine bladder, and the adjustment device may move the bending membersagainst the urethra or urine bladder to bend the latter to restrict theurine passageway. The restriction device may also rotate a portion ofthe urethra or urine bladder. The bending or rotating members may takeany shape and be either hydraulic or non-inflatable.

[0041] Alternatively, the two bending members one placed more distalthan the other may be rotated in opposite directions relative to eachother. With interconnecting means for example flexible bands between thebending members a restriction will occur between the bending memberswhen they are rotated.

[0042] Preferably the adjustment device is operable to adjust therestriction device to steplessly change the restriction of the urinepassageway in the urethra or urine bladder.

[0043] All embodiments according to the invention may be controlled by awireless remote control.

[0044] In accordance with an advantageous embodiment of the invention,there is provided a wireless remote control for non-invasivelycontrolling the operation device. The remote control may convenientlycomprise an external hand-held remote control unit, which is manuallyoperable by the patient to control the restriction device to squeeze andrelease the urethra or urine bladder. With the wireless remote controlthe apparatus of the invention is conveniently controlled by the patientwhen he so desires, which is of great advantage compared to the priorart procedures. With the remote control the apparatus of the inventionis conveniently controlled to adjust the implanted restriction device torelease the urine passageway when the patient wants to relieve himselfor herself.

[0045] The remote control may advantageously be capable of obtaininginformation related to important parameters, such as the condition ofthe urine passageway or the pressure against the restriction device, andof commanding the operation device to operate the adjustment device toadjust the restriction device in response to obtained information. Withthe remote control the apparatus of the invention is convenientlycontrolled to adjust the implanted restriction device to open and closethe urine passageway. The adjustment device may control the restrictiondevice to steplessly change the restriction of the passageway.

[0046] Preferably, the wireless remote control comprises a separatesignal transmitter or receiver and a signal receiver or transmitterimplanted in the patient. For example, the signal transmitter and signalreceiver may transmit and receive a signal in the form of digitalpulses, which may comprise a magnetic or electric field. Alternatively,which is preferred, the signal transmitter and signal receiver maytransmit and receive an electromagnetic wave signal, a sound wave signalor a carrier wave signal for a remote control signal. The receiver maycomprise an implanted control unit for controlling the adjustment devicein response to a control signal from the signal transmitter. Any knownor conventional signal transmitting or signal receiving means that issuitable for use with a human or mammal patient may be provided as thesignal transmitter or signal receiver.

[0047] The apparatus of the invention may further comprise an implantedenergiser unit for providing energy to energy consuming implantedcomponents of the apparatus, such as electronic circuits and/or a motorfor operating the adjustment device. Where a motor is provided thecontrol unit is adapted to power the motor with energy provided by theenergiser unit in response to a control signal received from the signaltransmitter. The motor may be any type of motor, such as a pneumatic,hydraulic or electric motor and the energiser unit may power the motorwith pressurized gas or liquid, or electric energy, depending on thetype of motor. Where the motor is an electric motor, it may powerpneumatic or hydraulic equipment.

[0048] The remote control advantageously comprises wireless energytransfer device for transferring energy from outside the patient's bodyto energy consuming implantable components of the apparatus. The energytransfer device may comprise said energiser unit is adapted to transformenergy from the control signal, as it is transmitted to the signalreceiver, into electric energy. Where the operation device comprises amotor the wireless energy transfer device is adapted to directly powerthe motor with transferred energy.

[0049] The energy transferred by the wireless energy transfer devicepreferably comprises a signal, suitably a wave signal. The energytransferred by the wireless energy transfer device may comprise anelectric field or a magnetic field or a combination thereof. The signalmay be analog or digital or a combination thereof. The energy transferdevice may transfer the energy from the signal into a direct, pulsatingdirect or alternating current or a combination thereof.

[0050] Any of the above mentioned signals may comprise analog or digitalpulses. The analog or digital signal may comprise a magnetic field or anelectric field or a combination thereof. Where the signal is a wavesignal it may comprise an electromagnetic wave signal, a sound wavesignal or a carrier wave signal for a remote control signal or acombination thereof. Where a carrier signal is used it may be frequency,amplitude or frequency and amplitude modulated.

[0051] The apparatus of the invention may comprise an implantable sourceof energy for powering the operation device and/or for energizing otherenergy consuming components of the apparatus, wherein the energy fromthe source of energy is releasable from outside the patient's body.Furthermore, the apparatus may comprise an energy transmission devicefor wireless transmission of energy of a first form and an energytransforming device implantable in the patient for transforming theenergy of the first form into energy of a second form, to be supplied tothe source of energy and/or other implantable energy consuming parts ofthe apparatus. The energy transforming device may transform the wirelessenergy directly or indirectly into energy different than the wirelessenergy for operation of the restriction device. Typically, the energy ofthe second form is different than the energy of the first form. Thefunction of the energy transmission device may be different from that ofthe energy transforming device.

[0052] An implantable motor or pump for operating the adjustment devicemay be provided, wherein the energy transmission device may be adaptedto transmit wireless energy in the form of a magnetic field orelectromagnetic waves or field for direct power of the motor or pump, asthe wireless energy is being transmitted. Suitably, the energytransmission device transmits energy by at least one signal separatefrom the above mentioned control signal.

[0053] An implantable stabiliser for stabilising the energy of the firstor second form may be provided. Where the energy of the second formcomprises electric current, the stabiliser suitably comprises at leastone capacitor.

[0054] Generally, the source of energy comprises a battery, accumulator,capacitor or a combination thereof.

[0055] In accordance with an embodiment of the invention, the apparatuscomprises a control device adapted to produce wireless energy fordirectly powering the operation device and/or for energizing otherenergy consuming components of the apparatus.

[0056] It should be understood that the energy consuming parts of theapparatus for example a motor or pump may be or may not be energisedwith the unchanged wirelessly transmitted energy as this beingtransmitted as well as being or not being energised with energydifferent than the transmitted energy for example transformed intoelectrical energy but still directly used for energising the energyconsuming parts of the apparatus as the transmitted energy istransmitted. Alternatively the energy consuming parts of the apparatusmay be energised from a implanted source of energy or storage device,which still may be loaded with wireless energy. In all these aspects itis preferable to be able to wirelessly control the release of energy andget an feedback of the result of the performed function of the device.Direct use of transmitted energy may be unrelaible without a feedbackwhat has happened, has the energy reached it's goal?

[0057] Generally, the wireless energy may comprise a wave signalincluding a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal or a gammaradiation signal.

[0058] Any of the above mentioned signals may comprise a wave signalincluding a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal or a gammaradiation signal.

[0059] The control device may be adapted to produce wireless energy inthe form of a train of energy pulses and the energy transfer device maybe adapted to intermittently transfer the train of energy pulses fordirect use in connection with the energising of the energy consumingcomponents of the apparatus. Alternatively, the control device may beadapted to control the energy transforming device to produce the energyof the second form in said train of energy pulses for direct use inconnection with the operation of the adjustment device. The transferredenergy preferably comprises electric energy. An implantable capacitormay be provided for producing the train of energy pulses.

[0060] Where a capacitor is used in any of the above describedembodiments it may have a relatively low capacity, i.e. less than 0.1μF, in order to be small and suited for implantation.

[0061] Where the operation device comprises an implantable motor or pumpfor operating the adjustment device, the energy transfer device may beadapted to directly power the motor or pump with transferred energy, atthe same time as the energy is transferred. Where a pump is used itshould not be a plunger type of pump, because a plunger pump is noisy,but may comprise a peristaltic or membrane pump.

[0062] As mentioned above the apparatus comprises a wireless remotecontrol for non-invasively controlling the operation device, whichpreferably is electrically powered. Alternatively, the operation deviceis powered by magnetic energy, non-magnetic energy, electromagneticenergy, non-electromagnetic energy, kinetic energy, non-kinetic energy,sonic energy, non-sonic energy, thermal energy or non-thermal energy.However, the operation device may be unpowerable by permanent staticmagnetic energy. Any other kind of energy, such as electric,electromagnetic energy or a moving permanent magnetic energy, may beconceivable for operating the adjustment device. As a result, theimplanted restriction device would not be accidentally adjusted if thepatient comes close to any permanent magnet. Suitably, the operationdevice is adapted to non-invasively operate the adjustment device.

[0063] Where the operation device comprises a hydraulic operation deviceit may use hydraulic fluid, the viscosity of which changes when thehydraulic fluid is exposed to energy, preferably electric energy,different than thermal energy. However, use of hydraulic fluid of thekind having a viscosity that increases when exposed to heat or amagnetic field, i.e. the hydraulic fluid would not become substantiallymore viscous when exposed to heat or influenced by magnetic forces,should be avoided, because external heat sources or heat from the bodywhen the patient has fever and external magnetic sources might affectthe implanted components of the apparatus.

[0064] The adjustment device is may be operable to adjust therestriction device to steplessly change the restriction of the urinepassageway. Furthermore, the adjustment device may be adapted tomechanically adjust the restriction device. Alternatively, it may beadapted to hydraulically adjust the restriction device by usinghydraulic means, which is devoid of hydraulic fluid of the kind having aviscosity that substantially increases when exposed to heat or amagnetic field.

[0065] In accordance with an embodiment of the invention, the apparatuscomprises a control device for controlling the restriction device. Thecontrol device may comprise an internal programmable control unitimplantable in the patient and, possibly an external control unitoutside the patient's body for programming the programmable internalcontrol unit. Alternatively, the external control unit may beprogrammable and wirelessly control the restriction device. The controldevice may be adapted to produce wireless energy for directly poweringthe operation device and/or for energizing other energy consumingcomponents of the apparatus.

[0066] At least one sensor for sensing at least one physical parameterof the patient may conveniently be implanted in the patient. The sensormay preferably sense as the physical parameter the horizontal positionof the patient or may comprise a pressure sensor for sensing thepressure against the restriction device or the urethra or urine bladderor other important parameters. The pressure sensor may be any suitableknown or conventional pressure sensor such as shown in U.S. Pat. Nos.5,540,731, 4,846,181, 4,738,267, 4,571,749, 4,407,296 or 3,939,823; oran NPC-102 Medical Angioplasty Sensor.

[0067] Either the internal control unit or the external control unit ofthe control device may suitably control the restriction device toenlarge or close the urine passageway. For safety the restriction devicemay enlarge or open the urine passageway in response to the sensorsensing for example an abnormally high pressure value. The internalcontrol unit may directly control the restriction device in response tosignals from the sensor.

[0068] Wherever magnetic means is utilized according to the invention itmay comprise a permanent magnet and a magnetic material reed switch, orother suitable known or conventional magnetic means.

[0069] Where a source of energy is used the control device suitably isoperable from outside the patient's body for controlling the source ofenergy to release energy for use in connection with the operation of theadjustment device, when the adjustment device is implanted. The sourceof energy may be provided external to the patient's body, and thecontrol device may be adapted to control the external source of energyto release wireless energy for use in connection with the operation ofthe adjustment device.

[0070] The control device may control the source of energy to releasemagnetic energy, non-magnetic energy, electromagnetic energy,non-electromagnetic energy, kinetic energy, non-kinetic energy, sonicenergy, non-sonic energy, thermal energy or non-thermal energy,preferably in a non-invasive manner and for a determined time periodand/or in a determined number of energy pulses.

[0071] Where the implantable components of the apparatus compriseelectrical electrical components they may include at least one or asingle voltage level guard. In this case, the electrical componentssuitably are devoid of any current detector and/or charge leveldetector. Furthermore, the electrical components may comprise acapacitor or accumulator, wherein the charge and discharge of thecapacitor or accumulator is controlled by use of the voltage levelguard. As a result, there is no need for any implanted current detectorand/or charge level detector for the control of the capacitor, whichmakes the apparatus simple and reliable.

[0072] In accordance with an advantageous embodiment of the invention,the apparatus comprises an implantable switch for directly or indirectlyswitching the operation of the restriction device. The switch may beoperated by the energy supplied by the energy transmission devicementioned above to switch from an off mode, in which the implantablesource of energy mentioned above is not in use, to an on mode, in whichthe source of energy supplies energy for the operation of therestriction device.

[0073] In accordance with an alternative embodiment, the above mentioneda remote control may be employed for controlling the implantable sourceof energy, wherein the switch is operated by the energy supplied by theenergy transmission device to switch from an off mode, in which theremote control is prevented from controlling the source of energy andthe source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.

[0074] In accordance with another alternative embodiment, the switch isoperated by the energy supplied by the implantable energy transformingdevice mentioned above to switch from an off mode, in which the sourceof energy is not in use, to an on mode, in which the source of energysupplies energy for the operation of the restriction device.

[0075] In accordance with yet another alternative embodiment, the switchis operated by the energy supplied by the energy transforming device toswitch from an off mode, in which the remote control is prevented fromcontrolling the source of energy and the source of energy is not in use,to a standby mode, in which the remote control is permitted to controlthe source of energy to supply energy for the operation of therestriction device.

[0076] Suitably, the restriction device is embedded in a soft orgel-like material, such as a silicone material having hardness less than20 Shore.

[0077] The energy transforming device may be designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.

[0078] The adjustment device may be adapted to adjust the restrictiondevice such that the restriction device provides a predeterminedcontraction of the urine passageway that is satisfactory for thepatient.

[0079] The adjustment device is preferably adapted to adjust theprosthesis device in a non-flux magnetic or non-thermal manner ornon-viscosity changing manner, because these would give rise tounreliable function of the device. The expression “non-viscositychanging manner” should be understood to mean that the adjustment deviceis not adjusted by changing the viscosity of the hydraulic fluid used.

[0080] All the above described various components, such as the motor,pump and capacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable. Specifically, the various remote controlfunctions described and all the various methods for supplying energy maybe used in any conceivable combination that is apparent to those skilledin the art.

[0081] The invention also provides a method for treating a patientsuffering from urinary incontinence, comprising the steps of placing atleast two laparascopical trocars in the body of a patient suffering fromurinary incontinence, inserting a dissecting tool through the trocarsand dissecting an area of the urethra or urine bladder in the abdominalor pelvic or retroperitoneal surroundings, placing at least oneadjustable restriction device in the dissected area engaging the urethraor urine bladder adjusting the restriction device to normally restrictthe urine passageway in the urethra or urine bladder, and adjusting therestriction device to open the urine passageway when the patient wantsto relieve himself or herself. A hydraulic adjustable restriction devicemay be used when practicing this method, preferably in a non-manualmanner, i.e. without touching subcutaneously implanted components of theapparatus.

[0082] The method may further comprise implanting a source of energy inthe patient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy for theadjustment of the restriction device.

[0083] The present invention also provides a method for treating urinaryincontinence, comprising surgically implanting in the body of a patientsuffering from urinary incontinence an adjustable restriction deviceengaging the urethra or urine bladder to restrict the urine passageway,and when desired to allow the patient to urinate, adjusting therestriction device to temporarily release the urethra or urine bladderto open the urine passageway. The method may further comprise implantingan elongated restriction member of the restriction device around theurethra or urine bladder.

[0084] The urinary incontinence treatment apparatus of the invention mayalso be laparoscopicly implanted. Thus, there is provided a methodcomprising the steps of placing at least two laparascopical trocars inthe patient's body, inserting a dissecting tool through the trocars anddissecting an area of the pelvic or abdominal or retroperitonealsurroundings and placing an operable restriction device in the dissectedarea, so that the restriction device engages the urethra or urinebladder to restrict the urine passageway.

[0085] The invention is described in more detail in the following withreference to the accompanying drawings, in which

[0086] FIGS. 1A-D are block diagrams of four different principalembodiments of the urinary incontinence treatment apparatus according tothe invention.

[0087] FIGS. 2A-D are cross-sectional views of a pump mechanismaccording to FIG. 1C, which is designed to pump fluid in oppositedirections by mechanically pushing a wall portion in only one direction.

[0088]FIG. 3 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 1B or2B.

[0089]FIG. 4 is a cross-sectional view of a reservoir having a variablevolume adjustable by manual manipulation, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 1B or1D.

[0090]FIG. 5A is a perspective view of a hydraulic, pneumatic ormechanical servo system in accordance with a particular embodiment ofthe principal embodiment shown in FIG. 1D.

[0091]FIG. 5B is a cross-sectional view taken along line VB-VB of FIG.5A.

[0092]FIG. 6 is a block diagram illustrating remote control componentsof the device of the invention;

[0093]FIG. 7 is a schematic view of exemplary circuitry used for theblock diagram in FIG. 4;

[0094]FIG. 8 is a schematic view af a band with a cavity defining arestriction opening for use in accordance with the invention.

[0095]FIGS. 9A and 9B are schematic views of a first mechanicalrestriction device for use in accordance with the invention;

[0096]FIGS. 10A and 10B are schematic views of a second mechanicalrestriction device for use in accordance with the invention;

[0097]FIG. 11 is a schematic view of a third mechanical restrictiondevice for use in accordance with the invention;

[0098]FIG. 12A is a schematic front view of a fourth mechanicalrestriction device for use in accordance with the invention;

[0099]FIGS. 12B and 12C are sectional views along the line A-A of FIG.12A;

[0100]FIGS. 13A through 17B are five modifications of the embodiment ofFIGS. 12A-12C;

[0101]FIG. 18 is a view of an inflatable restriction device of theapparatus of the invention: and FIG. 19 illustrates the apparatus of theinvention implanted in a patient.

[0102] Referring to the drawing figures, like reference numeralsdesignate identical or corresponding elements throughout the severalfigures.

[0103] FIGS. 1A-D is a block diagram of four different embodiments ofthe urinary incontinence treatment apparatus according to the invention.FIG. 1A shows an elongated restriction member in the form of a band 2forming a loop which defines a restriction opening. The band 2 providesa restricted urine passageway in the urethra when applied around thelatter. FIG. 1A further shows a separate reservoir 4, a one way pump 6and an alternate valve 8. FIG. 1B shows the band 2 and a fluid supplyreservoir 10. FIG. 1C shows the band 2, a two way pump 12 and thereservoir 4. FIG. 1D shows a servo system with a first closed systemcontrolling a second system. The servo system comprises the fluid supplyreservoir 10 and a servo reservoir 14. The servo reservoir 14 controls alarger adjustable reservoir 16 which in connection with the band 2applied around the urethra varies the volume of a cavity in the band,which in turn varies the restricted urine passageway in the urethra.Such a band 2 forming the restriction opening 3 is illustratedschematically in FIG. 8. The band 2 comprises an adjustment devicehaving an expandable/contractabe cavity 5 which is expanded orcontracted by supplying hydraulic fluid (e.g. from reservoir 4, 6, 10,or 16), and the band 2 may be sutured in place, illustratedschematically at 7 in FIG. 8.

[0104] FIGS. 2A-D are cross-sectional views of a pump mechanism adaptedto pump fluid in both directions only by mechanically pushing a separatesealing wall portion 18 in one direction. FIG. 2A shows a piston 20pushed forwards against a spring 22 towards the wall portion 18 andlocated in a pump housing 24 conducting fluid from a right upper fluidpassage 26 of the housing 24 to a left fluid passage 28 of the housing24. A main valve 30 is open and a nonreturn valve 32 is closed. FIG. 2Billustrates the first pump movement in which the piston 20 has movedforwards and reaches the wall portion 18. FIG. 2C illustrates how thepiston 20 moves backwards by the action of the spring 22. The main valve30 is now closed and the nonreturn valve 32 is open for fluid from theright upper passage 26. FIG. 1D illustrates how the piston 20 is movedfurther downwards from its position according to FIG. 2B while pushingthe wall portion 18 downwardly against a second spring 34 that isstronger than spring 22, whereby fluid escapes from a right lower fluidpassage 36. When moving the piston 20 backwardly from the positionaccording to FIG. 2D, fluid enters the left fluid passage 28 and a valve38 in the lower right fluid passage 36 closes.

[0105]FIG. 3 is a cross-sectional view of a reservoir 40 defining achamber 42, the volume of which is variable by an operation device inthe form of a remote controlled electric motor 44, in accordance withFIG. 1B or 1D. The reservoir 40 and the motor 44 are placed in a housing46. The chamber 42 is varied by moving a large wall 48. The wall 48 issecured to a nut 50, which is threaded on a rotatable spindle 52. Thespindle 52 is rotated by the motor 44 via an angular gearing, whichcomprises two conical gear wheels 54 and 56 in mesh with each other. Themotor 44 is powered by a battery 58 placed in the housing 46. An signalreceiver 60 for controlling the motor 44 is also placed in the housing46. Alternatively, the battery 58 and the signal receiver 60 may bemounted in a separate place. The motor 44 may also be powered by energytransferred from transmitted signals.

[0106]FIG. 4 is a cross-sectional view of a reservoir 62 defining achamber 64, the volume of which is variable and is controlled by manualmanipulation. A gable wall portion 66 of an open ended inner cylindricalhousing 68 is adapted to be pushed downwards to fit in a desired lockinggroove 70 of a plurality of locking grooves 70 on the mantle wall of thecylindrical housing 68 to reduce the volume of the chamber 64. The innercylindrical housing 68 is suspended by springs 72 and is telescopicallyapplied on an outer cylindrical housing 74. When pushing the innercylindrical housing 68 it moves downwards relative to the outercylindrical housing 74 causing the gable wall portion 66 to release fromthe locking groove 70 and move upwards relative to the inner cylindricalhousing 68. When the inner housing 68 is moved upwardly by the action ofthe springs 72 the volume of the chamber 64 is increased.

[0107]FIGS. 5A and 5B show a servo means comprising a main ring-shapedfluid reservoir 76 defining a chamber 78, the volume of which isvariable. Centrally positioned in the main ring-shaped reservoir 76there is a servo fluid reservoir 80 defining a chamber 82, the volume ofwhich is variable. The chamber 82 of the servo reservoir 80 issubstantially smaller than the chamber 78 of the main reservoir 76. Thetwo reservoirs 76 and 80 are situated between two opposite separatewalls 84 and 86, and are secured thereto. When changing the amount offluid in the servo reservoir 80, the two opposite walls 84,86 are movedtowards or away from each other, whereby the volume of the chamber 78 ofthe main reservoir 76 is changed.

[0108]FIG. 6 shows the basic parts of a remote control system of theapparatus of the invention including the electric motor 44 of theembodiment shown in FIG. 3. In this case, the remote control system isbased on the transmission of electromagnetic wave signals, often of highfrequencies in the order of 100 kHz-1 gHz, through the skin 130 of thepatient. In FIG. 6, all parts placed to the left of the skin 130 arelocated outside the patient's body and all parts placed to the right ofthe skin 130 are implanted. Any suitable remote control system may beused.

[0109] An external signal transmitting antenna 132 is to be positionedclose to a signal receiving antenna 134 implanted close to the skin 130.As an alternative, the receiving antenna 134 may be placed for exampleinside the abdomen of the patient. The receiving antenna 134 comprises acoil, approximately 1-100 mm, preferably 25 mm in diameter, wound with avery thin wire and tuned with a capacitor to a specific high frequency.A small coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

[0110] An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either increaseor decrease the size of the restriction opening defined by the loop ofthe restriction member 2. The microprocessor starts a command byapplying a high frequency signal on the antenna 132. After a short time,when the signal has energized the implanted parts of the control system,commands are sent to increase or decrease the size of the restrictionopening of the restriction member 2 in predefined steps. The commandsare sent as digital packets in the form illustrated below. Startpattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

[0111] The commands are sent continuously during a rather long timeperiod (e.g. about 30 seconds or more). When a new increase or decreasestep is desired the Count byte is increased by one to allow theimplanted control unit 138 to decode and understand that another step isdemanded by the external control unit 136. If any part of the digitalpacket is erroneous, its content is simply ignored.

[0112] Through a line 140, an implanted energizer unit 126 draws energyfrom the high frequency electromagnetic wave signal received by thereceiving antenna 134. The energizer unit 126 stores the energy in apower supply, such as a large capacitor, powers the control unit 138 andpowers the electric motor 44 via a line 142.

[0113] The control unit 138 comprises a demodulator and amicroprocessor. The demodulator demodulates digital signals sent fromthe external control unit 136. The microprocessor of the control unit138 receives the digital packet, decodes it and, provided that the powersupply of the energizer unit 126 has sufficient energy stored, sends asignal via a signal line 144 to the motor 44 to either increase ordecrease the size of the restriction opening of the restriction member 2depending on the received command code.

[0114] Alternatively, the energy stored in the power supply of theenergizer unit may only be used for powering a switch, and the energyfor powering the motor 44 may be obtained from another implanted powersource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect the battery to the control unit 138 inan “on” mode when the switch is powered by the power supply and to keepthe battery disconnected from the control unit in a “standby” mode whensaid switch is unpowered.

[0115] With reference to FIG. 7, the remote control system schematicallydescribed above will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theurinary incontinence apparatus. The power amplifier 150 amplifies thesignals and sends them to the external signal transmitting antenna 132.The antenna 132 is connected in parallel with a capacitor 152 to form aresonant circuit tuned to the frequency generated by the signalgenerator 148.

[0116] The implanted signal receiving antenna coil 134 forms togetherwith a capacitor 154 a resonant circuit that is tuned to the samefrequency as the transmitting antenna 132. The signal receiving antennacoil 134 induces a current from the received high frequencyelectromagnetic waves and a rectifying diode 160 rectifies the inducedcurrent, which charges a storage capacitor 158. A coil 156 connectedbetween the antenna coil 134 and the diode 160 prevents the capacitor158 and the diode 160 from loading the circuit of the signal receivingantenna 134 at higher frequencies. Thus, the coil 156 makes it possibleto charge the capacitor 158 and to transmit digital information usingamplitude modulation.

[0117] A capacitor 162 and a resistor 164 connected in parallel and adiode 166 forms a detector used to detect amplitude modulated digitalinformation. A filter circuit is formed by a resistor 168 connected inseries with a resistor 170 connected in series with a capacitor 172connected in series with the resistor 168 via ground, and a capacitor174, one terminal of which is connected between the resistors 168,170and the other terminal of which is connected between the diode 166 andthe circuit formed by the capacitor 162 and resistor 164. The filtercircuit is used to filter out undesired low and high frequencies. Thedetected and filtered signals are fed to an implanted microprocessor 176that decodes the digital information and controls the motor 44 via anH-bridge 178 comprising transistors 180,182,184 and 186. The motor 44can be driven in two opposite directions by the H-bridge 178.

[0118] The microprocessor 176 also monitors the amount of stored energyin the storage capacitor 158. Before sending signals to activate themotor 44, the microprocessor 176 checks whether the energy stored in thestorage capacitor 158 is enough. If the stored energy is not enough toperform the requested operation, the microprocessor 176 waits for thereceived signals to charge the storage capacitor 158 before activatingthe motor 44.

[0119]FIGS. 9A and 9B show an embodiment of the apparatus of theinvention comprising a restriction device 202 having an elongatedflexible restriction member 204, such as a belt, a cord or the like. Theflexible member 204 extends in a loop around the urethra.(Alternatively, the flexible member 204 may comprise two separate partson opposite sides of the urethra.) One portion 204A of member 204 isattached to a frame 208 and another portion 204B of member 204 oppositeportion 204A in the loop of the flexible member 204 is connected to anadjustment device 210, which is fixed to the frame 208. The adjustmentdevice 210 pulls the flexible member 204 away from portion 204A tosqueeze the urethra between two opposite lengths of the flexible member204 to thereby restrict the urine passageway, see FIG. 96A, and releasesthe urethra from the flexible member 204 to thereby increase the urinepassageway, see FIG. 9B.

[0120]FIGS. 10A and 10B show an embodiment of the apparatus of theinvention comprising a restriction device 212 having two plate or barelements 214 on opposite sides of the urethra 206. An adjustment device216 moves the elements 212 in parallel towards each other to squeeze theurethra 206 between the elements 212 to thereby restrict the urinepassageway, see FIG. 10A, and moves the elements 212 away from eachother to enlarge the urine passageway, see FIG. 10B.

[0121]FIG. 11 shows an embodiment of the apparatus of the inventioncomprising a restriction device 218 having two articulated clampingelements 220 positioned on opposite sides of the urethra 206. Anadjustment device 222 moves the clamping elements 220 toward each otherto clamp the urethra 206 between the clamping elements 220 to therebyrestrict the urine passageway, and moves the clamping elements 220 awayfrom each other to release the urethra 206 from the clamping elements220 to thereby enlarge the urine passageway.

[0122]FIGS. 12A, 12B and 12C show an embodiment of the apparatus of theinvention comprising a restriction device 224 having three bendingmembers in the form of cylindrical rollers 226, 228 and 230 displacedrelative one another in a row along the urethra 206 and positionedalternately on opposite sides of the urethra 206. (Alternatively, eachroller 226, 228 and 230 may take the shape of an hour-glass.) Anadjustment device 232 moves the two outer rollers 226,230 laterallyagainst the urethra 206 in one direction and the intermediate roller 228against the urethra 206 in the opposite direction to bend the urethra tothereby restrict the urine passageway, see FIG. 12B. To release theurethra from the rollers 226-230, the adjustment device 232 moves therollers 226-230 away from the urethra 206, see FIG. 12C.

[0123]FIGS. 13A through 17B schematically illustrates modifications ofthe above embodiment according to FIGS. 12A-12C. Thus, FIGS. 13A and 13Bshow an embodiment similar to that of FIGS. 12A-12C except that thebending members are oval and not rotatable. FIGS. 14A and 14B show anembodiment similar to that of FIGS. 13A and 13B except that the ovalbending members are rotatable to squeeze the urethra, see FIG. 14B, andto release the urethra, see FIG. 14A. FIGS. 15A and 15B show anembodiment similar to that of FIGS. 12A-12C except that the intermediateroller has a changeable diameter to squeeze the urethra, see FIG. 15B,and to release the urethra, see FIG. 15A. FIGS. 16A and 16B show anembodiment similar to that of FIGS. 10A-16C except that the elements arereplaced by two cylindrical rollers positioned on opposite sides of theurethra. Finally, FIGS. 17A and 17B show an embodiment substantiallysimilar to that of FIGS. 16A and 16B except that the restriction deviceis turned 90° to form an S-shaped curvature of the urethra.

[0124]FIG. 18 shows an example of a hudraulic restriction device 234 foruse in accordance with the invention. The restriction device 234comprises an elongated restriction member 236 having an inflatablecavity 238. A tube 240 connects the cavity 238 to a hydraulic fluidreservoir, not shown. The restriction member 236 may be wrapped aroundthe urethra. Alternatively, two restriction members 236 may be used.

[0125]FIG. 19 schematically illustrates how any of the above-describedembodiments of the urinary incontinence treatment apparatus of theinvention can be implanted in a patient. Thus, an implanted adjustablehydraulic restriction device 234 extends almost completely around theurethra 242 and the urethra 244 to be capable of squeezing the urethra242 as a single unit. An adjustment device in the form of an inflatablecavity in the restriction device 234 is adapted to adjust therestriction device 234 so that the urine passageway is restricted. Animplanted assembly 246 includes a hydraulic fluid reservoir and anoperation device (which may include a pump) for distributing hydraulicfluid between the reservoir and the inflatable/contractible cavity ofthe restriction device 234 via a fluid conduit 240. A wireless remotecontrol of the apparatus comprises an external signal transmitter 248,which may comprise a hand-held unit, and an implanted signal receiver,which is incorporated in the implanted assembly 246, includes a controlunit for controlling the-restriction device 234 in response to a controlsignal from the external transmitter. The signal receiver of theassembly 246 further includes an energizer unit which transforms energyfrom the control signal transmitted by the external transmitter intoelectric energy for energy consuming implanted components of theapparatus.

[0126] A pressure sensor 250 is implanted for sensing the pressure onthe restriction device 234. The control unit of the assembly 246controls the restriction device 234 to release the urethra 242 inresponse to the pressure sensor 250 sensing an abnormal high pressure.

[0127] There are a number of conceivable alternative embodiments of theinvention that give the same result as the above-described embodiments.For example, the microprocessor of the external and implanted,respectively, control units may be replaced by discrete components. Thepower amplifier of the external control unit may be omitted if thesignals generated by the signal generator are strong enough. Therefore,the invention is to be accorded the broadest interpretation of theappended claims to encompass all equivalent structures and assemblies.

1. A urinary incontinence treatment apparatus, comprising an adjustable restriction device (2) adapted to engage the urethra or urine bladder of a patient, who suffers from urinary incontinence, to form a restricted urine passageway in the urethra or urine bladder, an implantable adjustment device (5) for adjusting the restriction device (2) to restrict the urethra or urine bladder to close the urine passageway, or release the urethra or urine bladder to open the urine passageway, when the restriction device is implanted in the patient, and an implantable electrically powered operation device (6,8;10;12;10,14;76-86) for operating the adjustment device, characterised by a reservoir (4;10;16) implantable in the patient and containing hydraulic fluid, wherein the operation device (6,8;10;12;10,14;76-86) is adapted to operate the adjustment device (5) by using the hydraulic fluid of the reservoir.
 2. An apparatus according to claim 1, wherein the reservoir (4;10;16) contains a predetermined amount of hydraulic fluid.
 3. An apparatus according to claim 1, wherein the adjustment device comprises an expandable cavity (5) in the restriction device (2), the urine passageway being closed upon expansion of the cavity and open upon contraction of the cavity, and the operation device (6,8;10;12;10,14;76-86) is adapted to distribute hydraulic fluid from the reservoir (4;10;16) to expand the cavity, and to distribute hydraulic fluid from the cavity to the reservoir to contract the cavity.
 4. An apparatus according to claim 3, wherein the reservoir (10) defines a chamber (42;64) for said predetermined amount of fluid and the operation device is adapted to change the size of the chamber.
 5. An apparatus according to claim 4, wherein the operation device comprises first and second wall portions (48;66) of the reservoir (10) and is adapted to provide relative displacement between the first and second wall portions of the reservoir, in order to change the volume of the chamber (42;64).
 6. An apparatus according to claim 5, wherein the operation device is adapted to provide said relative displacement in response to the pressure in the reservoir.
 7. An apparatus according to claim 6, wherein the operation device comprises a pressure controlled hydraulic operation device.
 8. An apparatus according to claim 7, further comprising an alarm adapted to generate an alarm signal in response to the lapse of a predetermined time period during which the pressure controlling the hydraulic operation device exceeds a predetermined high value.
 9. An apparatus according to claim 5, wherein the first and second wall portions of the reservoir (10) are displaceable relative to each other by magnetic means, hydraulic means, or electric control means, or a combination thereof.
 10. An apparatus according to claim 5, wherein the operation device is adapted to distribute fluid from the reservoir (10) to the cavity (5) of the restriction device (2) in response to a predetermined first displacement of the first wall portion (48;66) of the reservoir relative to the second wall portion of the reservoir and to distribute fluid from the cavity to the reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion.
 11. An apparatus according to claim 3, wherein the operation device comprises a pump (6,12) adapted to pump fluid between the reservoir (4) and the cavity (5) of the restriction device (2).
 12. An apparatus according to claim 11, wherein the pump comprises a first activation member for activating the pump to pump fluid from the reservoir (4) to the cavity (5) of the restriction device (2) and a second activation member for activating the pump to pump fluid from the cavity to the reservoir.
 13. An apparatus according to claim 12, wherein the first and second activation members are operable by manual manipulation.
 14. An apparatus according to claim 12, wherein at least one of the activation members is adapted to operate when subjected to a predetermined external pressure.
 15. An apparatus according to claim 12, wherein at least one of the first and second activating members are operable by magnetic means, hydraulic means, electric control means or manual manipulation means, or a combination thereof.
 16. An apparatus according to any of claims 1-15, wherein the operation device comprises a servo means.
 17. An apparatus according to any of claims 5, 9 or 11 wherein the operation device comprises a reverse servo.
 18. A urinary incontinence treatment apparatus, comprising an adjustable restriction device (2) adapted to engage the urethra or urine bladder of a patient, who suffers from urinary incontinence, to form a restricted urine passageway in the urethra or urine bladder, an implantable adjustment device (5) for adjusting the restriction device (2) to restrict the urethra or urine bladder to close the urine passageway, or release the urethra or urine bladder to open the urine passageway, when the restriction device is implanted in the patient, and an implantable operation device (6,8;10;12;10,14;76-86) for operating the adjustment device, characterised in that the operation device comprises a servo means operatively connected to the adjustment device.
 19. An apparatus according to claim 18, wherein the operation device is powered.
 20. An apparatus according to claim 18, wherein the operation device is manually operated.
 21. An apparatus according to claim 18 or 19, wherein the servo means comprises a motor, preferably an electric motor.
 22. An apparatus according to claim 21, wherein the motor is reversible.
 23. An apparatus according to claim 21 or 22, further comprising a gearing connected between the motor and the adjustment device.
 24. An apparatus according to any of claims 18-20, further comprising an implantable reservoir (4;10;16) defining a chamber for hydraulic fluid, wherein the operation device is adapted to operate the adjustment device (5) by using the hydraulic fluid of the reservoir.
 25. An apparatus according to claim 24, Wherein the reservoir (4;10;16) contains a predetermined amount of hydraulic fluid.
 26. An apparatus according to any of claims 18-20 or 24-25 wherein the servo means comprises a reverse servo.
 27. An apparatus according to claims 24 and 26, wherein the the reservoir (204) comprises first and second wall portions and the reverse servo is adapted to provide relative displacement between the first and second wall portions of the reservoir, in order to change the volume of the reservoir.
 28. An apparatus according to claim 27, wherein the reverse servo device is adapted to provide said relative displacement in response to the pressure in the reservoir.
 29. An apparatus according to any of claims 18-28, wherein the servo means comprises a pressure controlled servo means.
 30. An apparatus according to claim 29, further comprising an alarm adapted to generate an alarm signal in response to the lapse of a predetermined time period during which the pressure controlling the servo means exceeds a predetermined high value.
 31. An apparatus according to claim 26, wherein the reverse servo comprises magnetic means, electric means or manual manipulation means or a combination thereof.
 32. An apparatus according to claim 27, wherein the reverse servo comprises hydraulic means (10,14, 76-86).
 33. An apparatus according to claim 32, wherein the reverse servo further comprises a servo reservoir defining a chamber containing servo fluid, and the operation device comprise first and second wall portions of the servo reservoir, which are displaceable relative to each other to change the volume of the chamber of the servo reservoir.
 34. An apparatus according to claim 33, wherein the first and second wall portions of the servo reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means.
 35. An apparatus according to claim 32, wherein the reverse servo comprises a servo reservoir (14) and a fluid supply reservoir (10) connected in a closed system and containing a further predetermined amount of fluid.
 36. An apparatus according to claim 35, wherein the fluid supply reservoir (10) defines a chamber for the further predetermined amount of fluid and the hydraulic operation device is adapted to change the volume of the chamber and thereby control the amount of fluid in the servo reservoir (14).
 37. An apparatus according to claim 36, wherein the fluid supply reservoir (10) comprises first and second wall portions, which are displaceable relative to each other to change the volume of the chamber of the fluid supply reservoir.
 38. An apparatus according to claim 37, wherein the fluid supply reservoir (10) increases the amount of fluid in the servo reservoir (14) in response to a predetermined first displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir and decreases the amount of fluid in the servo reservoir in response to a predetermined second displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir.
 39. An apparatus according to any of claims 1 or 18, wherein the adjustment device comprises a hydraulic adjustment device, and further comprising a reservoir implantable in the patient and containing a predetermined amount of hydraulic fluid, and a conduit providing fluid connection between the reservoir and the hydraulic adjustment device, the operation device being adapted to operate the hydraulic adjustment device by distributing hydraulic fluid through the conduit between the reservoir and the hydraulic adjustment device, the conduit and hydraulic adjustment device being devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in the conduit.
 40. An apparatus according to claim 39, wherein the reservoir forms a fluid chamber with a variable volume, and the operation device is adapted to distribute fluid from the chamber to the adjustment device by reduction of the volume of the chamber and to withdraw fluid from the adjustment device by expansion of the volume of the chamber.
 41. An apparatus according to claim 40, wherein the operation device comprises a motor or a pump.
 42. An apparatus according to claim 40 or 41, wherein the operation device comprises a movable wall of the reservoir for changing the volume of the chamber.
 43. An apparatus according to claim 42, wherein the operation device is adapted to change the volume of the chamber by moving the movable wall in response to the pressure in the chamber.
 44. An apparatus according to claim 4 or 24, further comprising an injection port subcutaneously implantable in the patient and in fluid communication with the chamber.
 45. An apparatus according to claim 44, wherein the injection port is integrated in the reservoir.
 46. An apparatus according to claim 1 or 18, wherein the restriction device comprises an elongated restriction member and forming means for forming the restriction member into at least a substantially closed loop around the urethra or urine bladder, the loop defining a restriction opening, whereby the adjustment device is adapted to adjust the restriction member in the loop to change the size of the restriction opening.
 47. An apparatus according to claim 46, wherein the forming means forms the restriction member (2) into a loop having a predetermined size or a size selected from several predetermined sizes.
 48. An apparatus according to claim 46, wherein the adjustment device is adapted to change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member is changed.
 49. An apparatus according to claim 46, wherein the adjustment device is adapted to change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member is unchanged.
 50. An apparatus according to claim 46, wherein the restriction member is non-inflatable, and the adjustment device is adapted to adjust the restriction member in said loop.
 51. An apparatus according to claim 34, wherein the adjustment device mechanically adjusts the restriction member.
 52. An apparatus according to claim 50, wherein the adjustment device hydraulically adjusts the non-inflatable restriction member.
 53. An apparatus according to claim 51 or 52, wherein the elongated restriction member (204) is flexible, and the adjustment device (210) is adapted to pull a first portion (204A) of the flexible restriction member from a second portion (204B) of the flexible restriction member opposite the first portion in the loop to squeeze the urethra or urine bladder between two opposite lengths of the elongated flexible restriction member to restrict the passageway, and to release the urethra or urine bladder from the flexible restriction member to enlarge the passageway.
 54. An apparatus according to claim 1 or 18, wherein the adjustment device mechanically adjusts the restriction device.
 55. An apparatus according to any of claims 1 or 18 or 39 or 54, wherein the restriction device (212) comprises at least two elements (214) to be placed on different sides of the urethra or urine bladder, and the adjustment device is adapted to squeeze the urethra or urine bladder between the elements to restrict the urine passageway in the urethra or urine bladder, and to release the urethra or urine bladder from the elements to enlarge the urine passageway (FIGS. 10A, 10B).
 56. An apparatus according to claim 1 or 18, wherein the restriction device (218) comprises at least two articulated clamping elements (220) to be positioned on opposite or different sides of the urethra or urine bladder, and the adjustment device (222) is adapted to turn the clamping elements toward each other to clamp the urethra or urine bladder between the clamping elements to restrict the urine passageway in the urethra or urine bladder, and to turn the clamping elements away from each other to release the urethra or urine bladder from the elements to enlarge the urine passageway (FIG. 11).
 57. An apparatus according to any of claims 1 or 18 or 39 or 54, wherein the restriction device is adapted to bend a portion of the urethra or urine bladder (FIGS. 12A-17B).
 58. An apparatus according to claim 41, wherein the restriction device (224) comprises at least two bending members (226-230) to be positioned on opposite sides of the urethra or urine bladder and to be displaced relative to each other along the urine passageway in the urethra or urine bladder, and the adjustment device (232) is adapted to move the bending members against the urethra or urine bladder to bend the urethra or urine bladder to restrict the urine passageway in the urethra or urine bladder, and to move the bending members away from the urethra or urine bladder to release the urethra or urine bladder from the bending members to enlarge the urine passageway (FIGS. 12A-12C).
 59. An apparatus according to claim 42, wherein the bending members comprise rollers.
 60. An apparatus according to claim 1 or 18, wherein the restriction device is adapted to rotate a portion of the urethra or urine bladder.
 61. An apparatus according to any of the preceding claims, further comprising a wireless remote control for non-invasively controlling the hydraulic operation device.
 62. An apparatus according to claim 61, wherein the remote control comprises an external wireless hand-held remote control unit which is manually operable by the patient to control the restriction device to squeeze or release the urethra or urine bladder.
 63. An apparatus according to claim 61, wherein the remote control comprises an external signal transmitter (132,136), receiver or transceiver and a signal receiver (134,138), transmitter or transceiver implantable in the patient.
 64. An apparatus according to claim 63, wherein the signal receiver (134,138) and/or transmitter comprises a control unit (138) adapted to control the operation device in response to a control signal received from the signal transmitter (132, 136).
 65. An apparatus according to claim 64, further comprising an implantable energizer unit (136) for providing energy to energy consuming implantable components of the apparatus.
 66. An apparatus according to any of claims 1,18 and 65, wherein the operation device comprises a motor (44) for operating the adjustment device.
 67. An apparatus according to claims 65 and 66, wherein the control unit (138) is adapted to power the motor (44) with energy provided by the energizer unit (136) in response to a control signal received from the signal transmitter (132,136).
 68. An apparatus according to claim 61, wherein the remote control comprises a wireless energy transfer device for transferring energy from outside the patient's body to energy consuming implantable components of the apparatus.
 69. An apparatus according to claim 65 and 68, wherein the energy transfer device comprises an implantable energizer unit (126), which is adapted to transform energy from the control signal, as it is transmitted to the signal receiver (134,138), into electric energy.
 70. An apparatus according to claim 68, wherein the operation device comprises a motor, and the wireless energy transfer device is adapted to directly power the motor with transferred energy.
 71. An apparatus according to claim 69 or 70, wherein the energy transferred by the wireless energy transfer device comprises a signal.
 72. An apparatus according to claim 71, wherein the signal comprises a wave signal.
 73. An apparatus according to claim 69 or 70, wherein the energy transferred by the wireless energy transfer device comprises an electric field or a magnetic field or a combination thereof.
 74. An apparatus according to claim 71, wherein the signal is analog or digital or a combination thereof.
 75. An apparatus according to claim 63 or 64, wherein the signal transmitter (132,136) and signal receiver (134,138) are adapted to transmit and receive an analog or digital signal or a combination thereof.
 76. An apparatus according to claim 74 or 75, wherein the signal comprises analog or digital pulses.
 77. An apparatus according to any of claims 74-76, wherein the analog or digital signal comprises a magnetic field or an electric field or a combination thereof.
 78. An apparatus according to claim 63 or 64, wherein the signal transmitter (132,136) and signal receiver (134,138) are adapted to transmit and receive a wave signal.
 79. An apparatus according to claim 71 or 78, wherein the wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal or a combination thereof.
 80. An apparatus according to claim 79, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.
 81. An apparatus according to claim 71 or 74 wherein the energy transfer means transfers the energy from the signal into a direct, pulsating direct or alternating current or a combination thereof.
 82. An apparatus according to claim 61, wherein the remote control is capable of obtaining information related to important parameters of the apparatus from inside the patient's body and of commanding the adjustment device (5) to adjust the restriction device (2) in response to obtained information.
 83. An apparatus according to claim 61, wherein the remote control is capable of obtaining information related to the urine passageway in the urethra or urine bladder and of commanding the adjustment device to adjust the restriction device in response to obtained information.
 84. An apparatus according to any of claims 1,18,39 and 54, further comprising an implantable source of energy for powering the operation device and/or for energizing other energy consuming components of the apparatus, wherein the energy from the source of energy is releasable from outside the patient's body.
 85. An apparatus according to any of claims 1,18,39 and 54, further comprising an energy transmission device for wireless transmission of energy.
 86. An apparatus according to claim 84 and 85, wherein the energy transmission device transmits energy of a first form, and further comprising an energy transforming device implantable in the patient for transforming the energy of the first form into energy of a second form, to be supplied to the source of energy and/or other implantable energy consuming parts of the apparatus.
 87. An apparatus according to claim 86, wherein the energy of the second form is different than the energy of the first form.
 88. An apparatus according to claim 86, wherein the energy transmission device functions differently from the energy transforming device.
 89. An apparatus according to claim 85, further comprising an implantable motor or pump for operating the adjustment device, wherein the energy transmission device is adapted to transmit wireless energy in the form of a magnetic field or electromagnetic waves or field for direct power of the motor or pump, as the wireless energy is being transmitted.
 90. An apparatus according to claims 64 and 85, wherein the energy transmission device transmits energy by at least one signal separate from the control signal.
 91. An apparatus according to claim 86, further comprising an implantable stabiliser for stabilising the energy of the first or second form.
 92. An apparatus according to claim 91, wherein the energy of the second form comprises electric current and the stabiliser comprises at least one capacitor.
 93. An apparatus according to any of claims 84,86-88, wherein the source of energy comprises a battery, accumulator, capacitor or a combination thereof.
 94. An apparatus according to any of claims 1,18,39 and 54, further comprising a control device adapted to produce wireless energy for directly powering the operation device and/or for energizing other energy consuming components of the apparatus.
 95. An apparatus according to any of claims 1,18,39 and 54, further comprising an implantable energy transforming device for transforming wireless energy directly or indirectly into energy different than the wireless energy for operation of the restriction device.
 96. An apparatus according to claim 94 or 95, wherein the wireless energy comprises a wave signal including a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultra violet light signal, a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal or a gamma radiation signal.
 97. An apparatus according to any of claims 1,18 and 94, further comprising an energy transfer device for wireless transfer of energy from outside the patient's body to the operation device or adjustment device and/or other energy consuming implantable components of the apparatus.
 98. An apparatus apparatus according to claim 94, wherein the control device is adapted to produce wireless energy in the form of a train of energy pulses.
 99. An apparatus according to claim 68 or 97, wherein the energy transfer device is adapted to intermittently transfer the energy in the form of a train of energy pulses for direct use in connection with the energising of the energy consuming components of the apparatus.
 100. An apparatus according to claims 94 and 86 wherein the control device is adapted to control the energy transforming device to produce the energy of the second form in a train of energy pulses for direct use in connection with the operation of the adjustment device.
 101. An apparatus according to claim 99 or 100, wherein the energy transfer device is adapted to transfer electric energy, and further comprising an implantable capacitor for producing the train of energy pulses.
 102. An apparatus according to any of claims 92,93 and 101, wherein the capacitor has a capacity less than 0.1 μF.
 103. An apparatus according to claim 97, further comprising an implantable motor or pump for operating the adjustment device, wherein the energy transfer device is adapted to directly power the motor or pump with transferred energy.
 104. An apparatus according to claim 89 or 103, wherein the pump is not a plunger type of pump.
 105. An apparatus according to any of claims 1,18,38 and 54, wherein the adjustment device is adapted to adjust the restriction device in a non-manual, non-thermal or non-magnetic manner.
 106. An apparatus according to any of claims 62-105, further comprising a wireless remote control for non-invasively controlling the operation device.
 107. An apparatus according to any of claims 1,18 and 89, wherein the operation device is unpowerable by static permanent magnetic energy.
 108. An apparatus according to any of claims 1,18,39 and 54, wherein the operation device is adapted to non-invasively operate the adjustment device.
 109. An apparatus according to any of claims 1,18,39 and 54, wherein the adjustment device is operable to adjust the restriction device to steplessly change the restriction of the urine passageway.
 110. An apparatus according to any of claims 1,18 and 39, wherein the operation device comprises a hydraulic operation device which uses hydraulic fluid, the viscosity of which changes when the hydraulic fluid is exposed to energy different than thermal energy.
 111. An apparatus according to claim 110, wherein the viscosity of the hydraulic fluid changes when the fluid is exposed to electric energy.
 112. An apparatus according to claim 1 or 18, further comprising an adjustment device for adjusting the restriction device to change the restriction of the urine passageway, wherein the adjustment device is adapted to mechanically adjust the restriction device, or adapted to hydraulically adjust the restriction device by using hydraulic means which is devoid of hydraulic fluid of the kind having a viscosity that substantially increases when exposed to heat or a magnetic field.
 113. An apparatus according to claim 1 or 18, further comprising a control device for controlling the restriction device.
 114. An apparatus according to claim 113, wherein the control device comprises an internal control unit implantable in the patient for controlling the restriction device.
 115. An apparatus according to claim 114, wherein the internal control unit is programmable.
 116. An apparatus according to claim 115, wherein the control device comprises an external control unit outside the patient's body, the implantable internal control unit being programmable by the external control unit.
 117. An apparatus according to claim 113, wherein the control device comprises an external control unit outside the patient's body for wirelessly controlling the restriction device.
 118. An apparatus according to claim 117, wherein the external control unit is programmable.
 119. An apparatus according to any one of the preceding claims, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.
 120. An apparatus according to claim 119, wherein the sensor is adapted to directly or indirectly sense as the physical parameter the horisontal position of the patient.
 121. An apparatus according to claim 119, wherein the sensor comprises a pressure sensor for directly or indirectly sensing as the physical parameter the pressure against the restriction device or part of the human body.
 122. An apparatus according to claim 121, wherein the restriction device is adapted to enlarge the urine passageway in the urethra or urine bladder in response to the pressure sensor sensing a predetermined pressure.
 123. An apparatus according to any one of claims 119-122, further comprising a control device for controlling the restriction device in response to signals from the sensor.
 124. An apparatus according to claim 123, wherein the control device comprises an internal control unit implantable in the patient and directly controlling the restriction device in response to signals from the sensor.
 125. An apparatus according to claim 124, wherein the control device comprises an external control unit outside the patient's body for controlling the restriction device in response to signals from the sensor.
 126. An apparatus according to claim 124, wherein the control device comprises an external control unit outside the patient's body for manually controlling the restriction device in response to information from the sensor.
 127. An apparatus according to claim 113, further comprising an implantable source of energy, wherein the control device is operable from outside the patient's body for controlling the source of energy to release energy for use in connection with the operation of the restriction device, when the restriction device is implanted.
 128. An apparatus according to claim 127, wherein the source of energy is intended to be external to the patient's body, and the control device is adapted to control the external source of energy to release wireless energy for use in connection with the operation of the restriction device.
 129. An apparatus according to claim 127, wherein the control device controls the source of energy to release magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, sonic energy, non-sonic energy, thermal energy or non-thermal energy.
 130. An apparatus according to any of claims 1,18,39 and 54, wherein the operation device is powered by magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, sonic energy, non-sonic energy, thermal energy or non-thermal energy.
 131. An apparatus according to claim 127, wherein the control device controls the source of energy to release energy for a determined time period.
 132. An apparatus according to claims 98 and 127, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.
 133. An apparatus according to claim 127, wherein the control device is adapted to control the source of energy to release energy in a non-invasive manner.
 134. An apparatus according to any of claims 1,18,39 and 54, further comprising implantable electrical components including at least one voltage level guard.
 135. An apparatus according to any of claims 1,18,39 and 54, further comprising implantable electrical components including a single voltage level guard.
 136. An apparatus according to claim 134 or 135, wherein the electrical components are devoid of any current detector and/or charge level detector.
 137. An apparatus according to any of claims 84, 101, 86, 92,93 and 134-136, further comprising an implantable capacitor or accumulator, wherein the charge or discharge of the capacitor or accumulator is controlled by use of the voltage level guard.
 138. An apparatus according to any of claims 64,69 and 90, wherein the control signal comprises a wave signal including a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultra violet light signal, a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal or a gamma radiation signal.
 139. An apparatus according to any of the preceding claims, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the restriction device.
 140. An apparatus according to claims 85 and 139, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, wherein the switch is operated by the energy supplied by the energy transmission device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the restriction device.
 141. An apparatus according to claims 85 and 139, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, and a remote control for controlling the supply of energy of the implantable source of energy, wherein the switch is operated by the energy supplied by the energy transmission device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the restriction device.
 142. An apparatus according to claims 86 and 139, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, wherein the switch is operated by the energy supplied by the energy transforming device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the restriction device.
 143. An apparatus according to claims 86 and 139, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, and a remote control for controlling the supply of energy of the implantable source of energy, wherein the switch is operated by the energy supplied by the energy transforming device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the restriction device.
 144. An apparatus according to any of claims 1,18,39 and 54, wherein the restriction device is operable to perform a reversible function.
 145. An apparatus according to claim 66 or 144, further comprising a reversing device implantable in the patient for reversing the function performed by the restriction device.
 146. An apparatus according to claim 145, wherein the control device controls the reversing device to reverse the function performed by the restriction device.
 147. An apparatus according to claim 145, wherein the reversing device comprises hydraulic means including a valve for shifting the flow direction of a flowing fluid in the hydraulic means.
 148. An apparatus according to claim 145, wherein the reversing device comprises a mechanical reversing device.
 149. An apparatus according to claim 145, wherein the reversing device comprises a switch.
 150. An apparatus according to claim 149, wherein the switch of the reversing device is operable by the released energy.
 151. An apparatus according to claim 150, wherein the control device controls the operation of the switch of the reversing device by shifting polarity of the released energy supplied to the switch.
 152. An apparatus according to claim 145, wherein the operation device comprises a motor, and the reversing device reverses the motor.
 153. An apparatus according to any of the preceding claims, wherein the restriction device is embedded in a soft or gel-like material.
 154. An apparatus according to claim 153, wherein the restriction device is embedded in a silicone material having hardness less than 20 Shore.
 155. An apparatus according to claim 86, wherein the energy transforming means or device is designed to be implanted subcutaneously or in the abdomen, thorax or cephalic region of the patient.
 156. An apparatus according to any of the preceding claims, wherein the adjustment device is adapted to adjust the restriction device such that the restriction device provides a predetermined contraction of the urine passageway that is satisfactory for the patient.
 157. An apparatus according to claim 1 or 18, wherein the adjustment device is adapted to adjust the restriction device in a non-flux magnetic, non-thermal or non-viscosity changing manner. 